DOCSLIB.ORG

United States District Court Northern District of Ohio Eastern Division

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
United States District Court Northern District of Ohio Eastern Division Case: 1:17-md-02804 Doc #: 3253 Filed: 04/03/20 1 of 60. PageID #: <pageID> UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF OHIO EASTERN DIVISION IN RE: NATIONAL PRESCRIPTION ) MDL 2804 OPIATE LITIGATION ) ) Case No. 1:17-md-2804 THIS DOCUMENT RELATES TO: ) ) Judge Dan Aaron Polster West Boca Medical Center, Inc. v. ) AmerisourceBergen Drug Corporation, et al. ) OPINION AND ORDER 1:18-op-45530 ) ) Before the Court are three separate motions to dismiss plaintiff West Boca Medical Center, Inc.’s (“West Boca,” or the “Hospital”) Complaint. Doc. #: 385.1 Distributors,2 Pharmacies,3 and Manufacturers4 each filed a group motion, seeking dismissal of West Boca’s claims against them.5 Doc. #: 684-1 (Distributors); Doc. #: 686 (Pharmacies); Doc. #: 691 (Manufacturers). West Boca filed an omnibus response in opposition that addressed all three 1 Unless otherwise indicated, all document numbers refer to the master MDL docket, Case No. 17-md-2804. Page numbers, when necessary, refer to the documents’ native format pagination. West Boca’s Complaint was refiled unredacted at Doc. #: 2985 and although the Court refers to the sealed complaint, Doc. #: 385, paragraph numbers in the unredacted version should be the same. 2 The Distributors’ motion was filed collectively by defendants AmerisourceBergen Drug Corporation (“ABDC”); Cardinal Health, Inc. (“Cardinal”); and McKesson Corporation (“McKesson”) (collectively, “Distributors” or “Distributor Defendants”). 3 The Pharmacies’ motion was filed collectively by defendants CVS Health Corporation (“CVS”); The Kroger Co. (“Kroger”); Walgreens Boots Alliance, Inc. (“Walgreens”); and Walmart Inc. (“Walmart”) (collectively “Pharmacies” or “Pharmacy Defendants”). 4 The Manufacturers’ motion was filed collectively by defendants Purdue Pharma LP, Purdue Pharma Inc., and The Purdue Frederick Company Inc. (“Purdue”); Allergan Finance, LLC f/k/a Actavis, Inc. f/k/a Watson Pharmaceuticals, Inc. (“Allergan”); Watson Laboratories, Inc., Actavis Pharma, Inc.; Actavis LLC; Teva Pharmaceuticals, USA, Inc.; and Cephalon, Inc. (“Teva”); Johnson & Johnson (“J&J”) and Janssen Pharmaceuticals, Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc., and Janssen Pharmaceutica, Inc. (“Janssen”); Endo Health Solutions Inc. and Endo Pharmaceuticals Inc. (“Endo”); Insys Therapeutics, Inc. (“Insys”); Mallinckrodt LLC (“Mallinckrodt”); and Noramco, Inc. (“Noramco”) (collectively “Manufacturers” or “Manufacturer Defendants”). 5 The Court recognizes that some Defendants have or are contemplating filing for bankruptcy protection, and litigation against those Defendants has or may be stayed pending those proceedings. For the sake of simplicity, the Court addresses these motions as they were filed by the parties. Case: 1:17-md-02804 Doc #: 3253 Filed: 04/03/20 2 of 60. PageID #: <pageID> motions. Doc. #: 806. Distributors and Pharmacies filed replies in support of their respective motions. Doc. #: 887 (Distributors); Doc. #: 890 (Pharmacies). Manufacturers also filed a reply in support of their motion. Case No. 18-op-45530, Doc. #: 55.6 West Boca later filed a notice of supplemental authority, Doc. #: 911, and then (purportedly on behalf of all hospitals whose cases have been transferred into this MDL) filed another notice of supplemental authority (“Second Notice”), Doc. #: 2618. Distributors filed a response to West Boca’s second notice. Doc. #: 2681. West Boca filed a reply to Distributors’ response, again on behalf of all hospitals in the MDL. Doc. #: 2705. West Boca then filed a third notice of supplemental authority. Case No. 1:18-op-45530, Doc. #: 65.7 The Court has reviewed all of the parties’ submissions. For the reasons stated below, the Court now rules as follows: Defendants’ Motions to Dismiss are GRANTED with respect to Count II (RICO § 1962(a)); Count V (Breach of Implied Warranty); Count VIII (Negligence Per Se); Count IX (Negligent Marketing); and Count X (Negligent Distribution). The motions are otherwise DENIED. I. Legal Standard for a Motion to Dismiss The principles governing review of a Motion to Dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6) are well-settled, as this Court has previously articulated. See, e.g., Report and Recommendation (“R&R”) on Motions to Dismiss Muscogee (Creek) Nation Claims, Doc. #: 1499 at 2-3; R&R on Motion to Dismiss Summit County Claims, Doc. #: 1025 at 2-3. A court is “required to ‘accept all well-pleaded factual allegations of the complaint as true and 6 The Manufacturers’ Reply was not filed on the master MDL docket. 7 Additionally, on April 5, 2019, various hospital plaintiffs, including West Boca, filed a tangentially-related Brief in Response to Defendants’ Briefing on the Viability of Public Nuisance Nationwide. Doc. #: 1523. 2 Case: 1:17-md-02804 Doc #: 3253 Filed: 04/03/20 3 of 60. PageID #: <pageID> construe the complaint in the light most favorable to the plaintiff.’” Dinwiddie v. Beshear, 2019 WL 4009835, at *2 (6th Cir. Apr. 24, 2019) (quoting Dubay v. Wells, 506 F.3d 422, 426 (6th Cir. 2007); see also Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). Federal courts require only “notice pleadings” containing “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). Accordingly, “a complaint need not contain ‘detailed factual allegations,’ however, it requires more than ‘labels and conclusion’ or ‘a formulaic recitation of the elements of a cause of action.’” Dinwiddie, 2019 WL 4009835, at *2 (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). Rule 8 “demands more than an unadorned, the-defendant-harmed-me accusation,” and a complaint will not “suffice if it tenders ‘naked assertion[s]’ devoid of ‘further factual enhancement.’” Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 557). A complaint will survive a motion to dismiss if it “contain[s] sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Id. (quoting Twombly, 550 U.S. at 570). Facial plausibility exists “when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. (citing Twombly, 550 U.S. at 556). Deciding if a complaint states a plausible claim for relief is “a context-specific task that requires the reviewing court to draw on its judicial experience and common sense.” Id. at 679. A district court may dismiss a complaint for failure to state a claim “only if it’s clear that no relief could be granted under any set of facts that could be proved consistent with the allegations.” Trollinger v. Tyson Foods, Inc., 370 F.3d 602, 615 (6th Cir. 2004) (quoting Swierzkiewickz v. Sorema N.A., 534 U.S. 506, 514 (2002)); Hishon v. King & Spalding, 467 U.S. 69, 73 (1984)). II. Factual Allegations In its Complaint, West Boca asserts the following claims: 3 Case: 1:17-md-02804 Doc #: 3253 Filed: 04/03/20 4 of 60. PageID #: <pageID> Count I, Violation Of RICO,8 18 U.S.C. 1961, et seq. – Opioid False Narrative Enterprise (Against All Defendants); Count II, Violation Of RICO, 18 U.S.C. § 1962(a)&(d) (Against All Defendants); Count III, Violation Of Florida’s Deceptive And Unfair Trade Practices Act (Fla. Stat. Ann. § 501.201, et seq.) (Against All Defendants); Count IV, Fraudulent Practices – Misleading Advertising, Florida Statutes Title XLVI, Crimes § 817.41 (Against Marketing Defendants);9 Count V, Breach of Implied Warranty of Fitness For a Particular Purpose (Fla. Stat. Ann. §§ 672.315 and 672.11, et seq.) (Against All Defendants); Count VI, Negligence (Against All Defendants); Count VII, Wanton Negligence (Against All Defendants); Count VIII, Negligence Per Se (Against All Defendants); Count IX, Negligent Marketing (Against Marketing Defendants); Count X, Negligent Distribution (Against All Defendants); Count XI, Nuisance (Against All Defendants); and Count XII, Unjust Enrichment (Against All Defendants). Many of the factual allegations that pertain to the Defendants’ alleged behavior are the same as those alleged in the complaints filed in the (i) Summit County, (ii) Muscogee (Creek) 8 Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. 1961, et seq. 9 In its Complaint, West Boca uses the following definitions: “Collectively, Purdue, Actavis, Cephalon, Janssen, Endo, Insys, and Mallinckrodt are referred to as ‘Marketing Defendants.’” See Doc. #: 385 at ¶131. West Boca’s definition of Janssen includes J&J and Noramco, thus the “Marketing Defendants” are the same as the Manufacturers defined in footnote 4 by their joint participation in the Manufacturers’ Motion to Dismiss. “Cardinal, McKesson, and AmerisourceBergen are collectively referred to as the ‘Distributor Defendants.’” Doc. #: 385 at ¶148. “Collectively, Defendants CVS, Kroger, Rite Aid, Walgreens, and Wal-Mart are referred to as ‘National Retail Pharmacies.’” Doc. #: 385 at ¶154. Although incorporated in this definition, Rite-Aid of Maryland, Inc. was voluntarily dismissed on May 29, 2018. See Case No. 18-op-45530, Doc. #: 5; see also Doc. #: 760 (redacted complaint filed with Rite Aid removed). “Additionally, the Distributor Defendants and the National Retail Pharmacies are collectively referred to as the ‘Supply Chain Defendants.’” Doc. #: 385 ¶154. 4 Case: 1:17-md-02804 Doc #: 3253 Filed: 04/03/20 5 of 60. PageID #: <pageID> Nation, and (iii) Blackfeet Tribe cases.10 See Doc. ##: 514; 731; 6.11 The Magistrate Judge and this Court have addressed those factual allegations at length. See Summit County R&R,
Load more

Recommended publications
  • Pharmaceutical and Medical Device Tort Practice Trusted Advisors to the Health Sciences Industry
    Pharmaceutical and Medical Device Tort Practice Trusted Advisors to the Health Sciences Industry Today’s product liability cases reach far beyond one courtroom, requiring more than Product Liability a case-by-case approach. Because we take a strategic approach to litigation, King & “Law Firm of the Spalding’s product liability practice is recognized as one of the best in the nation. Year” in 2016 Recognizing that our clients need to protect their businesses, including the continued viability of their products in the marketplace, our lawyers work together with both Law360 our FDA & Life Sciences practice group and our Government Investigations team to provide a 360° defense. As one client noted, “Cases can spill over into other things _________________ like regulatory issues … King & Spalding can bring it all.” And we do. • The largest health law practice in the nation, according to the American Health Mass Tort / Class Lawyers Association, providing additional depth of experience on healthcare Action “Law Firm regulatory and litigation issues. of the Year” in 2015 • A stable of specialists in the relevant sciences, as well as former FDA and DEA regulatory officials who provide highly sophisticated support to our litigation defense. U.S. News & World • IP attorneys who successfully represent biotechnology and pharmaceutical Report clients in prosecuting, obtaining and defending patents. _________________ Trial Ready When Needed We add to our strategic approach a range of trial experience that is increasingly Life Sciences “Law unusual in firms of our size. We try cases every year throughout the nation. With four Firm of the Year” in Fellows in the American College of Trial Lawyers, an organization whose members 2017 are elected based on actual courtroom experience, we serve notice to opposing counsel that they should not count their cases as settled.
    [Show full text]
  • Purdue Pharma to Pay $270 Million to Settle Historic Oklahoma Opioid Lawsuit
    Purdue Pharma to pay $270 million to settle historic Oklahoma opioid lawsuit (CNN) — Purdue Pharma has agreed to pay $270 million to settle a historic lawsuit brought by the Oklahoma attorney general, who accused the OxyContin maker of aggressively marketing the opioid painkiller and fueling a drug epidemic that left thousands dead in the state. The settlement comes after Purdue fought the attorney general in court, seeking to delay the start of the trial, which is scheduled for May 28. "It is a new day in Oklahoma, and for the nation, in our battle against addiction and the opioid epidemic," Attorney General Mike Hunter said Tuesday in Tulsa. Hunter said that $102.5 million of the settlement would be used to help establish a national addiction treatment and research center at Oklahoma State University, with additional payments of $15 million each year for the next five years beginning in 2020. The company will also provide $20 million of addiction treatment and opioid rescue medications to the center over the same five-year time frame. A remaining $12.5 million from the settlement will be used directly to help cities and counties with the opioid crisis. The Sackler family, who founded and own Purdue Pharma, will also contribute $75 million over the next five years to the treatment and research center. "Purdue is very pleased to have reached an agreement with Oklahoma that will help those who are battling addiction now and in the future," Dr. Craig Landau, president and CEO of Purdue Pharma, said in a statement. The lawsuit was brought by Hunter against some of the nation's leading makers of opioid pain medications, alleging that deceptive marketing over the past decade fueled the epidemic in the state.
    [Show full text]
  • XCHANGE COMMISSION Washington, D.C
    UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) (X) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 1999 ( ) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 0-19034 REGENERON PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) New York 13-3444607 (State or other jurisdiction of (I.R.S. Employer Identification No) incorporation or organization) 777 Old Saw Mill River Road, Tarrytown, New York 10591-6707 (Address of principal executive offices) (Zip code) (914) 347-7000 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: None (Title of Class) Securities registered pursuant to Section 12(g) of the Act: Common Stock - par value $.001 per share (Title of Class) Preferred Share Purchase Rights expiring October 18, 2006 (Title of Class) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes /X/ No Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (ss. 229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.
    [Show full text]
  • Virginia: in the Circuit Court of Pittsylvania County
    VIRGINIA: IN THE CIRCUIT COURT OF PITTSYLVANIA COUNTY PITTSYLVANIA COUNTY, Plaintiff, v. PURDUE PHARMA, L.P.; PURDUE PHARMA, INC.; THE PURDUE FREDERICK COMPANY, INC.; RHODES PHARMACEUTICALS, L.P.; ABBOTT LABORATORIES; ABBOTT LABORATORIES, INC.; MALLINCKRODT PLC; MALLINCKRODT LLC; ENDO HEALTH SOLUTIONS, INC; ENDO PHARMACEUTICALS, INC.; PAR Case No. CL18 - __________ PHARMACEUTICAL COMPANIES, INC.; PAR PHARMACEUTICAL, INC.; TEVA Jury Trial Demanded PHARMACEUTICALS USA, INC.; CEPHALON, INC.; BARR LABORATORIES, INC.; JANSSEN PHARMACEUTICALS, INC.; ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC.; JANSSEN PHARMACEUTICA, INC.; WATSON LABORATORIES, INC.; ALLERGAN PLC; ACTAVIS PHARMA, INC.; ACTAVIS, LLC; INSYS THERAPEUTICS, INC.; KVK-TECH, INC.; AMNEAL PHARMACEUTICALS LLC; IMPAX LABORATORIES, LLC; AMNEAL PHARMACEUTICALS, INC.; AMNEAL PHARMACEUTICALS OF NEW YORK, LLC; MYLAN PHARMACEUTICALS, INC.; MCKESSON CORPORATION; MCKESSON MEDICAL-SURGICAL INC.; CARDINAL HEALTH, INC.; AMERISOURCEBERGEN DRUG CORPORATION; HENRY SCHEIN, INC.; GENERAL INJECTABLES & VACCINES, INC.; INSOURCE, INC.; CVS HEALTH CORPORATION; CVS PHARMACY, INC.; CVS TN DISTRIBUTION, L.L.C.; WALGREENS BOOTS ALLIANCE, INC.; WALGREEN CO.; EXPRESS SCRIPTS HOLDING COMPANY; EXPRESS SCRIPTS, INC; CAREMARK RX, L.L.C.; CAREMARKPCS HEALTH, L.L.C.; CAREMARK, L.L.C.; UNITEDHEALTH GROUP INCORPORATED; OPTUM, INC.; OPTUMRX, INC.; and DOES 1-100, Defendants. PLAINTIFF’S ORIGINAL COMPLAINT Plaintiff, Pittsylvania County, Virginia, by and through the undersigned attorneys, (hereinafter “Plaintiff,” “Pittsylvania
    [Show full text]
  • Surescripts, Llc As Amicus Curiae in Support of Petitioners in No
    Nos. 19-508 and 19-825 In the Supreme Court of the United States ———————————— AMG CAPITAL MANAGEMENT, LLC, ET AL., Petitioners, v. FEDERAL TRADE COMMISSION, Respondent. ———————————— FEDERAL TRADE COMMISSION, Petitioner, v. CREDIT BUREAU CENTER, LLC, ET AL., Respondents. ———————————— ON WRITS OF CERTIORARI TO THE UNITED STATES COURTS OF APPEALS FOR THE SEVENTH AND NINTH CIRCUITS ———————————— BRIEF OF SURESCRIPTS, LLC AS AMICUS CURIAE IN SUPPORT OF PETITIONERS IN NO. 19-508 AND RESPONDENTS IN NO. 19-825 ———————————— ALFRED C. PFEIFFER, JR. ROMAN MARTINEZ LATHAM & WATKINS LLP Counsel of Record 505 Montgomery Street AMANDA P. REEVES Suite 2000 ALLYSON M. MALTAS San Francisco, CA 94111 DOUGLAS C. TIFFT BLAKE E. STAFFORD JAMES A. TOMBERLIN* LATHAM & WATKINS LLP 555 Eleventh Street, NW Suite 1000 Washington, DC 20004 (202) 637-2200 [email protected] Counsel for Amicus Curiae Surescripts, LLC TABLE OF CONTENTS Page TABLE OF AUTHORITIES ...................................... ii INTEREST OF AMICUS CURIAE ............................1 SUMMARY OF ARGUMENT .....................................3 ARGUMENT ...............................................................5 I. The FTC Has Increasingly Wielded Section 13(b) To Obtain Monetary Relief In Antitrust Cases ................................................5 II. The FTC’s Antitrust Authority Confirms That Section 13(b) Does Not Authorize Monetary Relief ..................................................22 CONCLUSION ..........................................................32 ii TABLE OF AUTHORITIES Page(s) CASES Apple Inc. v. Pepper, 139 S. Ct. 1514 (2019) .......................................... 13 Armstrong v. Exceptional Child Center, Inc., 575 U.S. 320 (2015) .............................................. 23 Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) .............................................. 26 In re Cardinal Health, Inc., No. 101-0006, 2015 WL 1849040 (F.T.C. Apr. 17, 2015) ........................ 19, 20, 28, 30 Credit Suisse Securities (USA) LLC v. Billing, 551 U.S.
    [Show full text]
  • Product Hopping 2.0: Getting the FDA to Yank Your Original License Beats Stacking Patents Lars Noah
    Marquette Intellectual Property Law Review Volume 19 | Issue 2 Article 2 Product Hopping 2.0: Getting the FDA To Yank Your Original License Beats Stacking Patents Lars Noah Follow this and additional works at: http://scholarship.law.marquette.edu/iplr Part of the Intellectual Property Commons Repository Citation Lars Noah, Product Hopping 2.0: Getting the FDA To Yank Your Original License Beats Stacking Patents, 19 Marq. Intellectual Property L. Rev. 161 (2015). Available at: http://scholarship.law.marquette.edu/iplr/vol19/iss2/2 This Article is brought to you for free and open access by the Journals at Marquette Law Scholarly Commons. It has been accepted for inclusion in Marquette Intellectual Property Law Review by an authorized administrator of Marquette Law Scholarly Commons. For more information, please contact [email protected]. NOAH FINAL (DO NOT DELETE) 5/9/2015 4:17 PM ARTICLES PRODUCT HOPPING 2.0: GETTING THE FDA TO YANK YOUR ORIGINAL LICENSE BEATS STACKING PATENTS LARS NOAH* INTRODUCTION .............................................................................................. 165 I.A PRIMER ON PRODUCT HOPPING IN THE PHARMACEUTICAL INDUSTRY ... 165 II. NEW & IMPROVED PRODUCT HOPPING: THE OXYCONTIN MANEUVER ... 172 CONCLUSION .................................................................................................. 179 * Professor of Law, University of Florida. NOAH FINAL (DO NOT DELETE) 5/9/2015 4:17 PM 162 MARQ. INTELL. PROP. L. REV. [Vol. 19:2 NOAH FINAL (DO NOT DELETE) 5/9/2015 4:17 PM 2015] PRODUCT HOPPING 2.0 163 Lars Noah is a Professor of Law at the Univeersity of Florida, where he has taught courses in Administrative Law, Biommedical Innoovation, Medical Technology, Public Health Law, and Torts, among other subjects.
    [Show full text]
  • PURDUE PHARMA, L.P., a Delaware Limited Partnership, PURDUE PHARMA INC., a New York Corporation, and RICHARD SACKLER, M.D
    IN THE CIRCUIT COURT OF BOONE COUNTY, WEST VIRGINIA STATE OF WEST VIRGINIA ex rel. PATRICK MORRISEY, Attorney General, Plaintiff, v. CIVIL ACTION NO. JUDGE PURDUE PHARMA, L.P., a Delaware limited partnership, PURDUE PHARMA INC., a New York corporation, and RICHARD SACKLER, M.D. Defendants. COMPLAINT This action is brought in the name of the State of West Virginia in its sovereign capacity by Patrick Morrisey, Attorney General, pursuant to W. Va. Code § 46A-7-108 of the West Virginia Consumer Credit and Protection Act, W. Va. Code § 46A- 1-101 et seq. ("WVCCPA"), against Purdue Pharma L.P., Purdue Pharma Inc., and Richard Sackler, M.D., to protect consumers and the integrity of the commercial marketplace in West Virginia. This action is brought against Richard Sackler individually and as a director on the Board of Purdue Pharma, Inc. The State also brings suit pursuant to the Attorney General's common law police power to abate and remedy the statewide public nuisance created by the Defendants' interference with the commercial marketplace and endangerment of the public health. BACKGROUND 1. In June 2001, the State of West Virginia, the Bureau of Employment Programs, West Virginia Department of Health and Human Services and the West Virginia Public Employees Insurance Agency sued Purdue Pharma L.P., Purdue Pharma Inc., and Purdue Frederick Company in the Circuit Court of McDowell County, West Virginia, Civil Action No. 01-C-137-S, for violations of the WVCCPA, in connection with the sale and marketing of OxyContin®. The parties entered into a settlement agreement that was approved by Final Order dated December 22, 2004 ("2004 Settlement").
    [Show full text]
  • Complaint, “Chronic Pain” Means Non-Cancer Pain Lasting Three Months Or Longer
    TABLE OF CONTENTS Page I. INTRODUCTION ...............................................................................................................1 II. JURISDICTION AND VENUE ..........................................................................................8 III. PARTIES .............................................................................................................................8 A. Plaintiff ....................................................................................................................8 B. Defendants ...............................................................................................................9 IV. FACTUAL ALLEGATIONS ............................................................................................14 A. Defendants Used Multiple Avenues To Disseminate Their False And Deceptive Statements About Opioids. ...................................................................14 1. Defendants spread and continue to spread their false and deceptive statements through direct marketing of their branded opioids. .......................................................................................................15 2. Defendants used a diverse group of seemingly independent third parties to spread false and deceptive statements about the risks and benefits of opioids.................................................................17 a. Key Opinion Leaders (“KOLs”) ....................................................19 (1) Russell Portenoy ................................................................20
    [Show full text]
  • Case 1:17-Cv-00450-UNA Document 1 Filed 04/20/17 Page 1 of 18 Pageid #: 1
    Case 1:17-cv-00450-UNA Document 1 Filed 04/20/17 Page 1 of 18 PageID #: 1 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PURDUE PHARMA L.P., PURDUE ) PHARMACEUTICALS L.P., THE P.F. ) LABORATORIES, INC., and RHODES ) TECHNOLOGIES, ) ) Plaintiffs, ) C.A. No. __________________ v. ) ) ABHAI, LLC and KVK-TECH, INC., ) ) Defendants. ) COMPLAINT Plaintiffs Purdue Pharma L.P., Purdue Pharmaceuticals L.P., The P.F. Laboratories, Inc. (collectively, “Purdue”), and Rhodes Technologies (“Rhodes”) (collectively, “Plaintiffs”), for their Complaint against Defendants Abhai, LLC (“Abhai”) and KVK-TECH, Inc. (“KVK”) (collectively, “Defendants”), aver as follows: NATURE OF THE ACTION 1. This is an action for patent infringement arising under the patent laws of the United States, Title 35, United States Code, for infringement of United States Patent Nos. 9,492,389 (“the ’389 patent”); 9,492,391 (“the ’391 patent”); 9,492,392 (“the ’392 patent”); 9,492,393 (“the ’393 patent”) and 9,522,919 (“the ’919 patent”) (collectively, “the patents-in- suit”). This action relates to Abbreviated New Drug Application (“ANDA”) No. 207493 (“Defendants’ ANDA”) submitted upon information and belief in the name of Defendants to the United States Food and Drug Administration (“FDA”). 2. Plaintiffs seek judgment that Defendants have infringed the ’389, ’391, ’392, ’393, and ’919 patents, which are listed in the FDA Approved Drug Products With Case 1:17-cv-00450-UNA Document 1 Filed 04/20/17 Page 2 of 18 PageID #: 2 Therapeutic Equivalence Evaluations (“Orange Book”) as covering Purdue’s OxyContin® (oxycodone hydrochloride) (“OxyContin®”), an extended-release pain medication.
    [Show full text]
  • Non-Merger Civil Enforcement: an Overview of Recent DOJ and FTC Federal Court Litigation
    Antitrust , Vol. 32, No. 1, Fall 201 7. © 2017 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association. Non-Merger Civil Enforcement: An Overview of Recent DOJ and FTC Federal Court Litigation BY SONIA KUESTER PFAFFENROTH ECENT YEARS HAVE SEEN THE As a result, there are now a significant number of career attor - Department of Justice and the Federal Trade neys and economists with recent federal trial court experience, Commission appearing with regularity in fed - which they will bring to future cases at the investigative phase eral district court, with the agencies demon - with an eye towards potential litigation. strating a willingness to litigate in both the Rmerger and non-merger context and with a number of high- DOJ Litigation profile trials now in the rearview mirror. Because the DOJ has no administrative adjudicative process, While the majority of civil conduct enforcement actions its civil enforcement cases, whether they are settlements or continue to be filed concurrently with settlements—which contested litigation, are filed directly in federal district court. provide significant insight into the government’s theories— In recent years, the DOJ has litigated a number of cases alleg - both agencies have seen an uptick in the number of contest - ing Section 1 violations and one case alleging a Section 2 vio - ed cases filed in federal district court since the beginning of lation.
    [Show full text]
  • FDA Listing of Authorized Generics As of July 1, 2021
    FDA Listing of Authorized Generics as of July 1, 2021 Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of d ata reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected] A B C D E F G H I J K L M N O P Q R S T U V X Y Z NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 1 ACANYA Gel 1.2% / 2.5% Bausch Health 07/2018 Americas, Inc.
    [Show full text]
  • November 26, 2018 Dr. Sol Barer Chairman of the Board Teva
    November 26, 2018 Dr. Sol Barer Chairman of the Board Teva Pharmaceutical Industries Limited Basel Street, P.O. Box 3190, Petach Tikva 4951033, Israel Dear Dr. Barer, We write to you as members of the Investors for Opioid Accountability (IOA) which represents a diverse global coalition of public, faith-based, labor, and sustainable funds, as well as asset managers with $2.2 trillion in assets under management.1 The IOA came together in 2017 out of concern for the potential risks that opioids present for the companies in which we invest. As global investors, we are writing to request a meeting with you to discuss potential financial, legal and reputational risks Teva Pharmaceutical Industries Limited (“Teva”) is facing related to the manufacturing and sale of opioids, and to ask that the Board consider adopting governance reforms designed to mitigate those risks. Opioid abuse is undeniably a public health crisis across North America and now spreading outside the U.S. as well. The U.S. Centers for Disease Control and Prevention (“CDC”) report that in 2016 alone, opioid abuse caused 42,249 deaths in the United States, or 115 people per day. In Canada, there were approximately 4,000 opioid-related deaths in 2017, a 34% increase from the prior year and a rate of 10.9 deaths per 100,000 people. In the UK and Wales, people dying from opioids related deaths in 2016 reached a record high of 3,700. In the U.S., the economic and social effects of the opioid crisis have been profound. Economist Alan Krueger has estimated that nearly 50% of prime age non-labor force men take prescription medication on a daily basis, with almost two-thirds of these being prescription pain medication.
    [Show full text]